The present invention relates to compositions of strong acid solutions and therapeutic methods therefore.
More particularly, the invention relates to the use of a composition comprising a mixture of strong and weak acids, the final composition acting as a buffer and having a pH of 1 or below.
Scientists are engaged in a constant battle to identify new therapeutics for treatment and prevention of disease in animals in general, and specifically in humans. The search for active agents which are useful against cancer is particularly acute. At present, a number of drugs are approved for treatment of cancer. Recent approvals include Taxol® (paclitaxel), Cisplatin®, Taxotere® (docetaxel). None of these products are active against all forms of cancer, all of them have significant side effects due to their cytotoxic effect on otherwise healthy cells. Due to the extreme toxicity of most cancer therapeutics, treating the cancer with such agents requires that the attending physician walk a fine line between treating the cancer and killing the patient. Patients experience severe discomfort and a noted reduction in quality of life due to side effects of chemotherapy such as alopecia, general disruption of the digestive system and feelings of malaise and general lack of well being. Despite the power of modem cytotoxic agents, many cancers such as glioblastoma are treated with only limited success using currently accepted medical practices. As such, there is a long felt need for additional cancer therapeutics. There is a particular need for therapeutics that offer efficacy, low side effects and generally improve a patient's quality of life.
Acids have been used in pharmaceutical chemistry for decades, primarily in the creation of acid addition salts of bases having therapeutic application. Lists of pharmacologically acceptable acids for the creation of such salts are well known and are exemplified throughout the patent literature. See U.S. Pat. No. 4,281,654 for a typical example.
The use of strong acids alone or in combination as a therapeutic is relatively unknown to the scientific community. However, there are a number of uses of acids as stabilizing agents. U.S. Pat. Nos. 5,733,888 and 5,977,164, entitled Injectable Composition and Stabilized Pharmaceutical Composition, issued to David Carver, et al., describe and claim the use of various acids for stabilizing a pharmaceutical formulation. Similarly, U.S. Pat. No. 5,504,102 also discloses the use of acids to stabilize a pharmaceutical composition.
The use of acid compositions alone is relatively unknown in the literature. U.S. Pat. No. 5,552,389 describes and claims a method of using Phosphoric acid diesters to treat liver cancer. Santillo, M., et al., Inhibitors of Ras Farnesylation Revert the Increased Resistance to Oxidative Stress in K-Ras Transformed NIH 3T3 Cells, 229(3) Biochem. Biophys. Res. Commun. 739–45 (December 1996) discloses that phosphonic acid may suppress certain tumor genes. Kwun, K. B., et al., Treatment of Metabolic Alkalosis with Intravenous Infusion of Concentrated Hydrochloric Acid, 146(3) Am J Surg 328–30 (September 1983) discloses the intravenous infusion of hydrochloric acid. Harguindey, S, et al., Effects of Systemic Acidification of Mice with Sarcoma 180, 39(11) Cancer Res 4364–71 (November 1979) discloses that mineral acidification of food decreased tumor growth and increased the rate of tumor regression.
Strong acid solutions having unique properties are disclosed in U.S. Pat. No. 4,675,120, issued to David J. Martucci, which describes and claims an acid composition comprising water, hydrochloric acid, phosphoric acid, oxalic acid, citric acid and hydrofluoric acid useful for crude oil recovery.
Topical cosmetic or disinfectant uses of a strong acid composition similar to that disclosed in U.S. Pat. No. 4,675,120 are disclosed in U.S. Pat. No. 5,512,200, which describes and claims a four acid core composition having very low pH comprised of a first and second inorganic acid and third and fourth organic acids. Inorganic acids disclosed include sulfuric, hydrochloric, hydrofluoric and phosphoric. Organic acids disclosed include oxalic and citric acids. The first and second acids are present in a concentration between 5 and 20%. The third and fourth inorganic acids are present in an amount between 1 and 5% of the final composition. The above composition is said to be useful when applied topically as an antibacterial or antifungal agent.
To date there has been no apparent development of strong acid solutions for pharmaceutical use. Particularly, there has been no effort to explore the potential internal uses for these unique agents.